Events

Recall of ASENA GH SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56590
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    While the pump is infusing a breakage of the plunger backplate spring may allow movement of the syringe plunger that may result in siphonage. neonatal and paediatric patients or those receiving critical drugs at low infusion rates would be considered to be the most at risk if small volumes of fluids reach the patient due to siphoning.

Device

ASENA GH SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE
  • Model / Serial
    Model Catalog: 80023GB01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80023FR01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80043UN01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80033UND1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8002MED01-G (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80033UND1-G (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80023UN01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8005TIG01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8005PK201 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80053UN01 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ASENA GH;ALARIS TIVA SYRINGE PUMP (REBRANDING);ALARIS CC SYRINGE PUMP (REBRANDING);ALARIS GH SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE (REBRANDING);ALARIS CC SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE (REBRANDING);ALARIS GH SYRINGE PUMP (REBRANDING);
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.